111medco 6% Sulfur Skin Cleansing Bar Soap
FDA Label NDC 72811-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 111medco Llc for the product 111medco 6% Sulfur Skin Cleansing Bar (NDC 72811-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sulfur 6%

Purpose

Acne

Uses

  • Cleansing soap for the management of acne.

Warnings

For external use only

When Using This Product

Skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.

Keep Out Of Reach Of Children.

If swallowed, get medial help or contact a Poison Control Center right away.

Directions

  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on problem areas, avoiding contact with eye
  • Rinse thoroughly and pat dry with a clean towel
  • Because bothersome dryness of the skin may occur, start with one use daily, then gradually increase to two or three times daily if needed
  • If bothersome drying or peeling occurs, reduce use to once a day or every other day

Inactive Ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, tangerine extract, sodium chloride, tetrasodium glutamate diacetate, rosemary leaf extract. (*may contain this ingredient)

Package Labeling:

Rlv3 (Revisedlabelv3)

Rlv3 (Revisedlabelv3)

* Please review the disclaimer below.